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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PROGRIP MESH PRODUCT
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Foreign Body Reaction (1868); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
Event Date 07/03/2017
Event Type  Injury  
Manufacturer Narrative
Title: long term results of open complex abdominal wall hernia repair with self-gripping mesh: a retrospective cohort study source: http://dx. Doi. Org/10. 1016/j. Ijsu. 2017. 07. 029 1743-9191/© 2017 ijs publishing group ltd. Published by elsevier ltd. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to a literature source of study performed between june 2012 and june 2015, that evaluated the safety and feasibility of the self-gripping polyester mesh in retromuscular position for the treatment of complex abdominal wall hernia repair. A total of 46 patients were treated in netherlands were included. Among them, 40 patients (87%) were diagnosed with incisional hernia. Seven patients (18%) had incisional hernia combined with another hernia. Four patients (8. 7%) had an umbilical hernia, one patient (2. 2%) had an epigastric hernia and one patient (2. 2%) had rectus diastasis. All hernias were considered as complex. Considering the short-term follow-up (three months): three patients had adverse events during primary hospital admission. One patient had an extended hospital stay of 17 days because of postoperative ileus, which was treated conservatively; one suffered from postoperative angina pectoris, one patient had postoperative pneumonia, and was successfully treated with antibiotics. Ten patients (21. 7%) were diagnosed with a postoperative seroma. One was treated with an ultrasound-guided puncture and nine patients were treated conservatively. Five patients showed an adverse event during outpatient follow-up. One patient showed a hematoma which was treated conservatively. Four patients were readmitted to the hospital for various reasons. Two were readmitted for 11 days and 5 days respectively because of administering intravenous antibiotics for the treatment of wound infection. In one patient this infection resulted in a mesh infection, which was treated conservatively. The other two patients were readmitted for diagnostic imaging of late abdominal complaints and ileus, which could not be explained by the surgical intervention. Considering the long-term follow-up, one patient (2. 6%) had a mesh infection after 4 months requiring mesh explantation and implantation of a biological mesh. Considering the short-term follow-up (three months): the median follow-up was 15 weeks (inter quartile range; iqr: 7-19 months) in which the median number of outpatient clinic visits was 3 (iqr: 2-4). None (0%) of the 46 patients had a recurrence during this period. At the outpatient clinic 38 patients (82. 6%) were without pain. Three patients (6. 5%) had mild abdominal pain without use of analgesics; four patients (8. 7%) used analgesics daily for moderate abdominal pain. One of the patients (2. 2%) suffered from severe pain. Long term follow up (one year or more): thirty-nine patients (85%) were included for long term follow up, median follow up was 25 months (iqr: 19-35 months). Median number of doctors' visits concerning hernia complaints was 0 (iqr 0-2). In total two patients (5. 1%) had a recurrence. One of these patients had a pseudobursa and recurrence after 17 months requiring reoperation. The other patient had a recurrence after 19 months requiring reoperation. Thirty patients (77%) reported no pain. Nine patients (23%) reported pain complaints with a mean visual analogue scale (vas) score of 1. 7 (range: 1-3).
 
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Brand NameUNKNOWN PROGRIP MESH PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12060649
MDR Text Key258163119
Report Number9615742-2021-01552
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PROGRIP MESH PRODUCT
Device Catalogue NumberUNKNOWN PROGRIP MESH PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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